Wristband that provides relief for upper limb tremor is approved; FDA warns of clinically significant weight loss in younger kids taking ADHD meds; REMS removed for CAR T-cell immunotherapies; ...

“While the phase 3 results of GCAptAIN did not replicate the positive outcomes observed in the phase 2 trial, we remain committed to continuing to drive scientific progress and deepening the ...

The Food and Drug Administration (FDA) has granted accelerated approval to Lynozyfic™ (linvoseltamab-gcpt) for the treatment of adult patients with ...

The approval of sunvozertinib, an oral irreversible EGFR inhibitor, was supported by data from the WU-KONG1B trial (ClinicalTrials.gov Identifier: NCT03974022 ). The primary efficacy population ...

The decision came Tuesday from US District Judge Melissa DuBose in response to a lawsuit filed by attorneys general from 19 states and the District of Columbia, the Associated Press reported. DuBose ...

The wearable, transcutaneous neurostimulation device delivers personalized therapy using a proprietary AI algorithm.

An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination ...

Gammagard Liquid ERC is a ready-to-use formulation with low IgA content designed to ease administration burden by removing the need to reconstitute.

The Food and Drug Administration (FDA) has approved an updated label for Amyvid (florbetapir F 18 injection) to support Alzheimer disease diagnosis in patients.

The approval was supported by pooled data from 2 open-label, single arm trials: the phase 2 NI-0501-06 study and the phase 3 EMERALD trial.

Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

HealthDay News — Attention-deficit/hyperactivity disorder (ADHD) medications remain associated with a reduced risk for various real-world outcomes, but the magnitude of these associations decreases ...